Unaccountable

U

The European Union and its Institutions have been heavily criticised as part of the Brexit debate as been undemocratic and unaccountable to the man or woman on the street. However, it is only when their decisions impact on you, or your patients, that you realise that these critics have a valid point. 

Last week the European Medicine Agency’s safety committee (PRAC or Pharmacovigilance Risk Assessment Committee) did something that makes me despair. They railroaded through changes to alemtuzumab’s SmPC (summary of product characteristics) against the advice of experts and without data to support their position. Their advice is therefore not evidence-based and as a result, it is likely to deny many pwMS access to one of our most effective DMTs. 

The PRAC states “Alemtuzumab should no longer be used in patients …. who have autoimmune disorders other than multiple sclerosis”. There is no evidence to support this statement. PwMS who have a pre-existing autoimmune disease are not at an increased risk of developing complications from alemtuzumab or secondary autoimmune disease when compared to pwMS who don’t have a pre-existing autoimmune disease. 

The problem I have is that the PRAC made this decision despite robust evidence to the contrary being presented by Genzyme and advice from experts in the field. I even co-signed a letter that Prof. Alasdair Coles penned to the PRAC, CHMP and MHRA, which clearly fell on deaf ears.

The behaviour of the PRAC reminds me of the Michael Gove interview with Faisal Islam on Sky News that took place on the 3rd June 2016 in the run-up to the Leave-Remain EU referendum: 

Gove: I think the people in this country have had enough of experts, with organizations from acronyms, saying—

Faisal Islam: They’ve had enough of experts? The people have had enough of experts? What do you mean by that?

Gove: People from organizations with acronyms saying that they know what is best and getting it consistently wrong.

Faisal Islam: The people of this country have had enough of experts?

Gove: Because these people are the same ones who got consistently wrong what was happening.

Faisal Islam: This is proper Trump politics this, isn’t it?

Gove: No it’s actually a faith in the —

Faisal Islam: It’s Oxbridge Trump.

Gove: It’s a faith, Faisal, in the British people to make the right decision.

Does the EMA expect us to have faith in their decision-making?

As an MSologist looking after pwMS this upsets me and worries me immensely. The implications of ignoring experts is one thing, but what are the implications for my patients? What impact will this PRAC decision have in practice?

I estimate that about a third of pwMS will have a comorbid autoimmune disease and may even be more than a third. The latter depends on how you define autoimmunity. This means many people with MS will be denied access to alemtuzumab because of EU officials who ignored the evidence presented to them and without any transparency around their thought processes and why they made this decision. This is no way for EU officials to be acting when we are trying to argue the case for Britain staying in the EU. 

Lack of transparency with the EMA is not new. I have been involved with many EMA-CHMP decisions and it really depends on the whim of rapporteur or co-rapporteur. Unlike the FDA which holds its meetings in the open, with the EMA and its various sub-committees you have no idea of the decision-making processes that go on behind closed doors. I am often asked why the British voted to leave the EU. The elephant in the room is the EU itself and how it functions; its decisions impact the lives of its citizens and this is another example of very, very, poor decision making with many downstream ramifications. 

CoI: multiple

About the author

Prof G

Professor of Neurology, Barts & The London. MS & Preventive Neurology thinker, blogger, runner, vegetable gardener, husband, father, cook and wine & food lover.

29 comments

  • The problem is that everyone thinks they are an expert these days and an expert in everything. So why did the EMA bother asking the experts if they were just going to ignore them?

      • They used the neurology SAG (specialist advisory group) who have some well know expert MSologists and trialists in the groups and on top of that they called in several heavyweights in the field. There was not a shortage of specialists/experts in the field.

        • Thanks.
          For the benefit of the readers the Neurology SAG is (below).
          I have done a quick search on their MS expertise

          Serge Bakchine (Chair) (MS papers = ~2)
          Anthony Johnson (MS papers = ~3. more on mouse)
          Ingo Kleiter (MS-papers = ~28. NMO interest
          Malcolm Macleod (MS papers = ~2. Stroke/meta analysis)
          Luca Massacesi (MS papers = ~67. HSCT)
          Edo Richard (MS papers = ~0)
          Michael Bjørn Russell (MS papers = ~1)
          Erich Schmutzhard (MS papers =~7)
          Pille Taba (Ms papers = ~3)

          Wow. I suppose most MS experts have been supported by pharma, so would be ineligible for EMA. MD Not an MS expert but an EAEologist. MS papers =~37 so more that all but 1 MS expert on the panel. Maybe I should volunteer:-)
          So thats in the red corner.
          In the Blue corner we have people like

          Giovannoni = >400
          Kappos = >500
          Coles = >90

    • The following is a definition of purdah: “Purdah is the period in the run-up to an election when there is a restriction in place on publicising the views of political parties, issuing press releases or promoting initiatives with quotes or photos from particular councillors as this could be seen to unfairly promote one particular political party”.

      I am not sure this issue has anything to do with a political party, but how the EMA makes decisions that are not evidence-based that potentially affect thousands of pwMS living in the EU.

    • Not so sure MD2 the letter went to the MHRA as well. They should have said something, but then again maybe they did and maybe the didn’t. Very frustrating if you are a person with MS who has just had your alemtuzumab request turned down because you have autoimmune hypothyroidism or type 1 diabetes.

    • Even if Brexit occurs there is a good chance the UK will stay a member of the EMA similar to what Norway does. But I agree with you the Swiss model may be better.

  • How crazy is this accoriding to CARE-MS, 56% of people will get autoimmune disease within 5 years of starting alemtuzumab treatment…..so this will signal the end of alemtuzumab access should disease breakthrough occur.

    • It is called a slow death. I wonder if a patient could take the EMA to court with a legal challenge about their process and the fact that their decision may be denying pwMS access to an effective treatment. At least a legal challenge will throw some light on the inner workings of the EMA.

    • Yep, absolute bonkers. You administer a drug knowing full well 50ish % will develop thyroid issues but that’s ok. But when they do, you can’t treat them anymore even though the thyroid issues can be effectively managed (and proportion self-resolve).

      I’m hearing rumours the Australian TGA are considering adopting the same looney restrictions.

  • I didn’t know that a third or more of pwMS will have a comorbid autoimmune disease

    Does one third of the population as a whole have an autoimmune disease?
    Or are people with MS particularly prone to autoimmune diseases?

  • Another bout of brickwallitis and depairism (oh the state of my forehead!) and I try so hard to remain positive🙄
    So now I’ve gotta worry not only about if (when) I experience disease breakthrough since receiving Alem, but also whether on not I’m in the 56% that get an autoimmune disease and therefore can’t have round three…
    More PwMS heading off to have HSCT then…

    • I guess if your hospital patient records could be looked at, to see if there is a correlation of pwMS weight and how many rounds of Alemtuzmab have been given and if there has been break through activity.

  • Do pwMS who have had Alemtuzumab and are less heavy in weight do better? As its the same dosage for all pwMS during each infusion. So a pwMS who is half the weight of another pwMS get the same dosage. Has this been looked into? I’m sure it has…..

    • As this is an intravenous infusion and the drug stays in the circulation rather than diffusing out to the rest of the body this is much less of an issue than for other drugs.

    • Good point if you are half the size you get twice the anticipated dose it is basic biology. If I had the individual data I could tell you but I dont have that

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